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FDAJanuary 18, 2017drug

Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL, a). 5 mL, 50 unit dose cups of 5 mL per case (NDC No. 66689-401-50), b). 500 mL, 12 bottles per case (NDC No. 66689-403-16), Rx only, Manufactured by VistaPharm, Largo, FL 33771.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.

What to do

FDA enforcement status: Terminated

Brands named

vistapharm

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL, a). 5 mL, 50 unit dose cups of 5 mL per case (NDC No. 66689-401-50), b). 500 mL, 12 bottles per case (NDC No. 66689-403-16), Rx only, Manufactured by VistaPharm, Largo, FL 33771. — Recall Details · AllClear